A Clinical Trial for the Interventional Robotic System

Cerebral Angiography Clinical Trial

Official title:

A Multi-Center, Randomized, Non-Inferiority, Prospective and Parallel-Group Trial to Evaluate the Safety and Efficacy of the Interventional Robotic System for Cerebral Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778214
• Other study ID #: P01-QR-003
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this multi-center clinical trial is to evaluate the efficacy and safety of the interventional robotic system for cerebral angiography, researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, etc.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: December 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age = 18 and = 85 years;

2. Plan to undergo cerebral angiography;

3. Voluntarily participated in this trial and signed the informed consent form.

Exclusion Criteria:

1. Preoperative mRS score >2;

2. Allergy or intolerance to iodine contrast media;

3. Allergy to interventional devices;

4. Severe cardiac, hepatic and renal insufficiency;

5. Active systemic infection;

6. Severe stenosis, occlusion or skin infection at the puncture site;

7. Subjects who are to undergo surgery at the same time as cerebral angiography;

8. Subjects with severe coagulation disorders, bleeding tendencies, or contraindications to anticoagulant drugs (e.g., heparin);

9. Subjects who are enrolled in clinical studies with other devices or drugs 3 months prior to screening;

10. Female subjects of childbearing age who are pregnant or breastfeeding;

11. Other subjects who, in the judgment of the investigator, are not suitable for participation in this trial.

Related Conditions & MeSH terms

• Cerebral Angiography

Intervention

Device:
• Interventional Robotic System
Cerebral angiography was performed by using the interventional robotic system

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai City

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success Rate	Assessment of the clinical success rate of the surgical physician in completing cerebral angiography examination through the operation of experimental instruments or artificial means.	at the end of surgery
Secondary	Super-selective Technique Success Rate	Assessing the technical success rate of the surgical physician in performing super-selective catheterization of cerebral vessels through the operation of experimental instruments or artificial means.	at the end of surgery
Secondary	Super-selective Catheterization Time for Target Vessels	Calculate and compare the average time taken to perform super-selective catheterization for each target vessel during each surgical procedure.	at the end of surgery
Secondary	DSA Fluoroscopy Time	Record and compare the duration of fluoroscopy during DSA for each surgical procedure.	at the end of surgery
Secondary	Surgical Time	Record and compare the duration of each surgical procedure.	at the end of surgery
Secondary	Primary Operator Radiation Absorbed Dose	Record and compare the absorbed dose of ionizing radiation received by the primary operator during each surgical procedure.	at the end of surgery
Secondary	Instrument Performance Evaluation	The surgical physician fills out a form after the surgery to subjectively evaluate the performance of the experimental instruments during the angiographic examination procedure.	at the end of surgery